The agency aims for the program to create a list of standards that can be hosted on its website that manufacturers can use as a reference prior to the FDA’s assessment of the quality of its products and its manufacturing processes.

Though the standards will be voluntary and will not change the requirements of the Federal Food, Drug, and Cosmetic Act, the FDA expects the agreed standards to streamline applications that successfully adhere to the points outlined between industry and the regulator.

In the FDA’s overview​ of the program, it noted that it specifically hopes that this course of action will improve the speed with which generics and biosimilars are manufactured, which should ‘spur competition’ on the market.

The Center for Drug Evaluation and Research (CDER) noted in the draft guidance that the program will “provide transparency to industry and other stakeholders regarding CDER’s thinking about a particular method or approach.”​

Will having a mutually agreed set of voluntary manufacturing standards result in a greater number of approvals and fewer manufacturing issues?

Yes, in the short-term, it should make requirements clearer

Yes, in the long-term, it will improve communication between stakeholders